If a WEE request is denied, the FDA will provide a written explanation for the denial. The trading partner may submit additional information or a revised request if appropriate.

Expedited review may be requested if there is an urgent need, such as an imminent risk to public health. However, the decision to expedite is at the FDA's discretion.

The review time for WEE requests can vary depending on the complexity of the request and the volume of submissions. The FDA aims to review and respond to requests as efficiently as possible, but there is no guaranteed timeframe.

Companies can apply to join the Beta Program for LSPedia’s WEE Management Module by clicking this link. Early adopters will have their license fees waived for 2024.

Yes, multiple waivers, exceptions, or exemptions can be requested in a single submission, provided each request is clearly justified and documented.

Yes, a WEE request can be submitted for products already in distribution if compliance with specific DSCSA requirements is infeasible or poses significant challenges.

No, there are currently no fees for submitting a WEE request to the FDA.

Without receiving DSCSA compliant EPCIS data, generating product trace information becomes challenging, potentially effecting your status as a preferred supplier.

WEE requests must be submitted electronically via the FDA's online portal. The submission should include detailed information about the request, the justification for the waiver, exception, or exemption, and any supporting documentation.

A WEE submission requires: - Identification of the specific DSCSA requirement(s) for which the request is being made. - A detailed explanation of the circumstances or conditions justifying the request. - Supporting documentation, such as risk assessments, scientific evidence, or other relevant data.- Contact information for the individual or entity submitting the request.